Multicenter results of a novel polyurethane hinged pupil expansion device for the management of small pupils during cataract surgery

Session Details

Session Title: Presented Poster Session: FLACS & Surgical Devices

Venue: Poster Village: Pod 1

First Author: : H.Uy PHILIPPINES

Co Author(s): :    K. Kenyon                       

Abstract Details

Purpose:

Small pupils present surgical challenges to the cataract surgeon and increase the level of risk for intra- and postoperative complications.   Pupil expansion devices facilitate surgical visualization by enlarging the pupil size.  We report the efficacy and safety of a new pupil expansion device for enlarging small pupils  during phacoemulsification cataract surgery.

Setting:

New England Eye Center, Boston Massachusetts, USA  and Ambulatory surgical center Peregrine Eye and Laser Institute, Makati, Philippines

Methods:

Interventional case series.  Fifty-seven eyes of 54 patients with small (< 4.0 mm), maximally dilated, pupils  underwent phacoemulsification cataract surgery and posterior chamber intraocular lens implantation.   The pupil was expanded using a novel,  single-use, hinged, polyurethane device (I-ring, Beaver Visitec International, Waltham, MA) designed to provide 6.8 mm pupil diameter.  The following data were obtained:  pre- and postoperative undilated pupil diameter (PD), pre- and postoperative dilated PD,  rate of successful deployment I-ring,  adverse events (eg. Pupil irregularity, sphincter tears, bleeding).

Results:

The mean(SD) age was 70.5(12.1) years.  The hinged PED was successfully applied in all eyes.  The mean PD at the undilated preoperative, dilated preoperative, dilated intraoperative,  with PED applied,  end of surgery, and, 1-month follow up visit stages were:   3.1± (1.1), 4.1± (1.1), 4.3 ±(1.1), 7.06.80± (0.00), 5.7 ±(1.1), and, 3.6 ±(0.78) mm, respectively.  There was a net increase in undilated PD by 0.5 mm after surgery (P=<0.0001, 95% CI, 0.0 to 0.5).  Postoperative pupil circularity was observed in 54 of 57 eyes (94.7%) with a mean (SD) eccentricity index of 0.11 ±(0.22).   No significant adverse events were observed.

Conclusions:

A novel, hinged PED safely achieved and maintained adequate pupil expansion and surgical visualization among in eyes with small pupils undergoing cataract surgery.  Good functional and aesthetic outcomes were obtained after hinged PED application and removal.  This novel device is a welcome addition to the small pupil surgical toolkit.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a competing company